Quetiapine Fumarate side effects: what 29,337 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Quetiapine Extended Release
Who reports
29,337 reports · 87% serious · 6,515 with death outcome · 63% female
Used for
Quetiapine extended-release tablets are an atypical antipsychotic indicated for the treatment of: Schizophrenia (1.1) Bipolar I disorder, manic or mixed episodes (1.2) Bipolar disorder, depressive episodes (1.2) Major depressive disorder, adjunctive therapy with antidepressants (1.3) 1.1 Schizophrenia Quetiapine extended-release tablets are indicated for the treatment of schizophrenia.
What it is
Quetiapine extended-release tablets are an atypical antipsychotic belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4] thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt.
Boxed warning
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] .
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,210 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Blood prolactin abnormal | 427 | 692.9 606.5–791.5ROR 703.1 · calibrated p 2e-15 ✓ | 344.4 EB05 317.8 · IC025 +7.8 3/3 methods agree | Lab value / disease marker | serious n=427 | not reported in cached trials |
| Anosognosia | 374 | 678.8 589.2–782.1ROR 687.6 · calibrated p 2e-15 ✓ | 340.1 EB05 312.1 · IC025 +7.7 3/3 methods agree | Not in label — unassessed | serious n=374 | not reported in cached trials |
| Lupus vulgaris | 517 | 553.3 493.4–620.5ROR 563.2 · calibrated p 2e-14 ✓ | 306.8 EB05 285.2 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=517 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Hepatic enzyme | 55 | 466.7 332.0–656.0ROR 467.5 · calibrated p 5e-13 ✓ | 256.1 EB05 204.2 · IC025 +5.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=55 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody | 247 | 422.2 360.8–494.1ROR 425.8 · calibrated p 4e-13 ✓ | 259.0 EB05 233.0 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=247 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Hypocholesterolaemia | 106 | 377.0 297.9–477.2ROR 378.4 · calibrated p 2e-12 ✓ | 235.5 EB05 200.2 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=106 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Deep vein thrombosis postoperative | 641 | 348.6 317.3–382.9ROR 356.4 · calibrated p 2e-12 ✓ | 231.9 EB05 217.2 · IC025 +7.5 3/3 methods agree | Not in label — unassessed | serious n=641 · ♀ 100% (drug 63%) · 91% clinician | not reported in cached trials |
| Grip strength | 71 | 316.5 239.2–418.6ROR 317.2 · calibrated p 1e-11 ✓ | 206.6 EB05 169.3 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=71 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Subcutaneous drug absorption impaired | 165 | 311.5 259.5–374.1ROR 313.3 · calibrated p 9e-12 ✓ | 211.0 EB05 185.4 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=165 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Sleep disorder due to general medical condition, hypersomnia type | 30 | 306.2 199.5–470.0ROR 306.5 · calibrated p 5e-11 ✓ | 188.3 EB05 138.2 · IC025 +5.0 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Tender joint count | 24 | 281.7 175.5–452.2ROR 281.9 · calibrated p 2e-10 ✓ | 173.8 EB05 122.9 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 63%) | not reported in cached trials |
| Retinitis | 436 | 253.3 227.2–282.5ROR 257.1 · calibrated p 5e-11 ✓ | 185.1 EB05 170.9 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=436 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Adjustment disorder with depressed mood | 521 | 249.8 226.2–275.8ROR 254.3 · calibrated p 5e-11 ✓ | 183.4 EB05 170.6 · IC025 +7.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=521 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Swollen joint count increased | 791 | 243.5 224.7–263.8ROR 250.2 · calibrated p 5e-11 ✓ | 180.4 EB05 170.1 · IC025 +7.2 3/3 methods agree | Lab value / disease marker | serious n=791 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Swollen joint count | 62 | 241.2 180.8–321.8ROR 241.7 · calibrated p 2e-10 ✓ | 170.6 EB05 137.8 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=62 · ♀ 100% (drug 63%) | not reported in cached trials |
| Dislocation of vertebra | 523 | 220.2 199.7–242.7ROR 224.1 · calibrated p 2e-10 ✓ | 166.9 EB05 155.3 · IC025 +7.0 3/3 methods agree | Not in label — unassessed | serious n=523 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Total lung capacity increased | 63 | 214.3 161.7–284.1ROR 214.8 · calibrated p 4e-10 ✓ | 156.8 EB05 126.9 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Rheumatic fever | 999 | 212.4 198.0–227.7ROR 219.8 · calibrated p 2e-10 ✓ | 162.9 EB05 154.6 · IC025 +7.1 3/3 methods agree | Not in label — unassessed | serious n=999 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Myoglobin urine present | 56 | 206.5 153.3–278.1ROR 206.9 · calibrated p 7e-10 ✓ | 151.7 EB05 121.2 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious n=56 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| C-reactive protein | 196 | 197.2 168.4–230.9ROR 198.5 · calibrated p 5e-10 ✓ | 152.0 EB05 135.0 · IC025 +6.6 3/3 methods agree | Lab value / disease marker | serious n=196 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Stubbornness | 86 | 176.6 139.4–223.6ROR 177.1 · calibrated p 2e-9 ✓ | 137.1 EB05 114.5 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=86 · ♀ 100% (drug 63%) | not reported in cached trials |
| X-ray abnormal | 346 | 172.1 153.1–193.4ROR 174.1 · calibrated p 1e-9 ✓ | 137.5 EB05 125.7 · IC025 +6.7 3/3 methods agree | Lab value / disease marker | serious n=346 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Personality change due to a general medical condition | 23 | 160.4 102.0–252.2ROR 160.5 · calibrated p 1e-8 ✓ | 118.2 EB05 83.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 100% (drug 63%) · 100% clinician | not reported in cached trials |
| Antipsychotic drug level below therapeutic | 126 | 158.5 130.7–192.2ROR 159.1 · calibrated p 4e-9 ✓ | 127.1 EB05 109.5 · IC025 +6.1 3/3 methods agree | Lab value / disease marker | serious n=125 · ♀ 17% (drug 63%) · 92% clinician | not reported in cached trials |
| Rheumatoid factor positive | 1,044 | 158.1 148.0–168.9ROR 163.9 · calibrated p 2e-9 ✓ | 129.0 EB05 122.5 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=1,044 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Anti-cyclic citrullinated peptide antibody positive | 1,262 | 154.5 145.5–164.0ROR 161.4 · calibrated p 3e-9 ✓ | 126.6 EB05 120.9 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious PRR 84.2 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Duodenal ulcer perforation | 1,213 | 141.6 133.3–150.4ROR 147.7 · calibrated p 5e-9 ✓ | 117.8 EB05 112.4 · IC025 +6.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 78.0 · ♀ 100% (drug 63%) · 93% clinician | not reported in cached trials |
| Facet joint syndrome | 517 | 140.3 127.8–154.1ROR 142.8 · calibrated p 7e-9 ✓ | 116.7 EB05 108.5 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious n=517 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Peripheral venous disease | 640 | 136.5 125.5–148.4ROR 139.5 · calibrated p 9e-9 ✓ | 114.1 EB05 106.9 · IC025 +6.6 3/3 methods agree | Labeled (related wording) related wording | serious n=638 · ♀ 99% (drug 63%) · 93% clinician | not reported in cached trials |
| Seronegative arthritis | 178 | 134.8 114.9–158.2ROR 135.6 · calibrated p 1e-8 ✓ | 112.0 EB05 98.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=178 · ♀ 100% (drug 63%) | not reported in cached trials |
| Disturbance in social behaviour | 368 | 131.6 117.8–147.0ROR 133.3 · calibrated p 1e-8 ✓ | 110.4 EB05 101.3 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious n=368 · ♀ 83% (drug 63%) | not reported in cached trials |
| Delusional disorder, persecutory type | 63 | 125.0 95.6–163.3ROR 125.2 · calibrated p 3e-8 ✓ | 103.0 EB05 83.4 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 0% (drug 63%) | not reported in cached trials |
| Pemphigus | 1,840 | 124.2 118.4–130.4ROR 132.5 · calibrated p 1e-8 ✓ | 105.6 EB05 101.7 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 70.1 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
| Growth hormone deficiency | 57 | 119.5 90.2–158.2ROR 119.7 · calibrated p 5e-8 ✓ | 99.0 EB05 79.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 0% (drug 63%) · 100% consumer | not reported in cached trials |
| Muscle injury | 1,112 | 112.1 105.3–119.2ROR 116.4 · calibrated p 4e-8 ✓ | 96.7 EB05 92.0 · IC025 +6.4 3/3 methods agree | Not in label — unassessed | serious PRR 69.0 · ♀ 100% (drug 63%) · 96% clinician | not reported in cached trials |
| Porphyria acute | 173 | 102.4 87.3–120.0ROR 103.0 · calibrated p 1e-7 ✓ | 88.7 EB05 78.1 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=173 · ♀ 100% (drug 63%) | not reported in cached trials |
| Helicobacter infection | 1,265 | 101.3 95.6–107.3ROR 105.8 · calibrated p 7e-8 ✓ | 88.5 EB05 84.5 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious PRR 62.0 · ♀ 100% (drug 63%) · 95% clinician | not reported in cached trials |
| Asthma-chronic obstructive pulmonary disease overlap syndrome | 63 | 98.4 75.6–128.0ROR 98.6 · calibrated p 2e-7 ✓ | 84.3 EB05 68.2 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=63 · ♀ 100% (drug 63%) · 92% clinician | not reported in cached trials |
| Temperature regulation disorder | 252 | 93.2 81.7–106.2ROR 94.0 · calibrated p 2e-7 ✓ | 81.9 EB05 73.8 · IC025 +5.9 3/3 methods agree | Labeled (related wording) related wording | serious n=251 · ♀ 100% (drug 63%) | not reported in cached trials |
| Hand deformity | 1,455 | 89.4 84.8–94.3ROR 94.0 · calibrated p 2e-7 ✓ | 79.4 EB05 76.0 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious PRR 57.1 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
Clinical concept groups
MedDRA splits one clinical problem across several terms (e.g. "neutropenia", "neutrophil count decreased", "agranulocytosis"), which dilutes term-level signals. These rows count reports with any term in a concept group (an exact union, not a sum), compared with all other drugs. Groups are hand-built and listed in the methods.
| Concept | Reports | PRR 95% CI | Reading |
|---|---|---|---|
| Extrapyramidal | 1,581 | 10.910.4–11.4 | signal |
| Suicidality | 3,651 | 10.810.4–11.1 | signal |
| Liver injury | 3,103 | 7.47.2–7.7 | signal |
| Interstitial lung disease | 952 | 7.26.7–7.6 | signal |
| Rhabdomyolysis / myopathy | 648 | 5.75.3–6.2 | signal |
| Depression | 2,008 | 5.14.9–5.4 | signal |
| Hyperglycaemia / diabetes | 2,245 | 4.74.5–4.9 | signal |
| Pancreatitis | 357 | 3.22.9–3.5 | signal |
| Hyponatraemia | 328 | 2.92.6–3.3 | signal |
| Arrhythmia / qt | 786 | 2.92.7–3.1 | signal |
| Serious infection | 2,810 | 2.62.5–2.7 | signal |
| Seizure | 566 | 2.11.9–2.2 | raised |
| Thrombocytopenia | 627 | 2.01.9–2.2 | raised |
| Fall / fracture | 943 | 1.81.7–1.9 | raised |
| Gi bleeding | 337 | 1.31.2–1.5 | raised |
| Kidney injury | 820 | 1.31.2–1.4 | raised |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Quetiapine Fumarate as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (0 of 40 signal terms matched).
- NCT00206102 — A Study of the Cataractogenic Potential of Seroquel and Risperdal in the Treatment of Participants With Schizo (N=1098, PHASE4; 151 AE terms posted; arms: Quetiapine Fumarate; Risperidone)
- NCT00600756 — Comparison of the Subjective Well-being and Tolerability of Quetiapine XR to Risperidone (N=798, PHASE3; 49 AE terms posted; arms: Quetiapine XR; Risperidone)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 3,723 | 2.0 2.0–2.1ROR 2.2 · calibrated p 0.965 | 2.0 EB05 2.0 · IC025 +1.0 | Reporting / coding artifact | age-adj. PRR 2.2 · serious PRR 3.4 | not reported in cached trials |
| Off label use (used outside approved label) | 3,233 | 2.7 2.6–2.8ROR 2.9 · calibrated p 0.668 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 2.4 · serious PRR 3.1 | not reported in cached trials |
| Fatigue (tiredness) | 2,746 | 2.5 2.4–2.6ROR 2.7 · calibrated p 0.736 | 2.5 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 1.9 · serious PRR 2.9 · ♀ 88% (drug 63%) | NCT00206102: 60/586 (10.2%) on Quetiapine Fumarate |
| Pain | 2,706 | 3.2 3.0–3.3ROR 3.4 · calibrated p 0.517 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 3.2 · ♀ 92% (drug 63%) | NCT00206102: 2/586 (0.3%) on Quetiapine Fumarate (serious AE) |
| Condition aggravated | 2,178 | 5.2 5.0–5.4ROR 5.5 · calibrated p 0.185 | 5.1 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | age-adj. PRR 4.4 · serious PRR 5.0 | not reported in cached trials |
| Headache | 2,153 | 2.5 2.4–2.6ROR 2.6 · calibrated p 0.780 | 2.5 EB05 2.4 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 1.8 · serious PRR 3.2 · ♀ 91% (drug 63%) | NCT00206102: 96/586 (16.4%) on Quetiapine Fumarate |
| Rheumatoid arthritis | 2,114 | 13.6 13.0–14.2ROR 14.6 · calibrated p 0.008 ✓ | 13.4 EB05 12.9 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 9.1 · serious PRR 10.8 · ♀ 99% (drug 63%) · 91% clinician | not reported in cached trials |
| Nausea | 2,109 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.935 | 1.9 EB05 1.8 · IC025 +0.9 | Labeled adverse reaction exact term | age-adj. PRR 1.5 · serious PRR 2.3 · ♀ 89% (drug 63%) | NCT00206102: 1/496 (0.2%) on Quetiapine Fumarate (serious AE) |
| Weight increased (weight gain) | 2,075 | 6.7 6.4–7.0ROR 7.1 · calibrated p 0.093 | 6.6 EB05 6.4 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | age-adj. PRR 5.4 · serious PRR 7.7 · ♀ 83% (drug 63%) | NCT00206102: 69/586 (11.8%) on Quetiapine Fumarate |
| Toxicity to various agents | 2,072 | 8.9 8.6–9.3ROR 9.5 · calibrated p 0.038 ✓ | 8.8 EB05 8.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | age-adj. PRR 6.7 · serious PRR 5.9 | not reported in cached trials |
| Rash | 2,070 | 3.4 3.3–3.6ROR 3.6 · calibrated p 0.459 | 3.4 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | age-adj. PRR 2.7 · serious PRR 4.8 · ♀ 94% (drug 63%) | not reported in cached trials |
| Vomiting | 2,062 | 3.2 3.0–3.3ROR 3.3 · calibrated p 0.532 | 3.1 EB05 3.0 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.5 · serious PRR 3.0 · ♀ 89% (drug 63%) | NCT00206102: 21/586 (3.6%) on Quetiapine Fumarate |
| Hypertension (high blood pressure) | 1,906 | 6.5 6.2–6.8ROR 6.9 · calibrated p 0.105 | 6.4 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 5.0 · serious PRR 5.3 · ♀ 89% (drug 63%) | NCT00206102: 1/496 (0.2%) on Quetiapine Fumarate (serious AE) |
| Dizziness | 1,842 | 2.7 2.5–2.8ROR 2.8 · calibrated p 0.709 | 2.6 EB05 2.5 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | age-adj. PRR 2.3 · serious PRR 2.9 · ♀ 85% (drug 63%) | NCT00206102: 2/496 (0.4%) on Quetiapine Fumarate (serious AE) |
| Pemphigus | 1,840 | 124.2 118.4–130.4ROR 132.5 · calibrated p 1e-8 ✓ | 105.6 EB05 101.7 · IC025 +6.6 3/3 methods agree | Not in label — unassessed | serious PRR 70.1 · ♀ 100% (drug 63%) · 94% clinician | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Anosognosia — n=374, PRR 678.8
- Lupus vulgaris — n=517, PRR 553.3
- Hypocholesterolaemia — n=106, PRR 377.0
- Deep vein thrombosis postoperative — n=641, PRR 348.6
- Grip strength — n=71, PRR 316.5
- Subcutaneous drug absorption impaired — n=165, PRR 311.5
- Tender joint count — n=24, PRR 281.7
- Retinitis — n=436, PRR 253.3
- Swollen joint count — n=62, PRR 241.2
- Dislocation of vertebra — n=523, PRR 220.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Quetiapine (antipsychotics) ↔ Diabetes mellitus.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Quetiapine Fumarate?
In FDA FAERS, the most frequently co-reported reaction terms for Quetiapine Fumarate are fatigue, pain, headache, rheumatoid arthritis, nausea, weight increased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Quetiapine Fumarate have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; AND SUICIDAL THOUGHTS AND BEHAVIORS Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Quetiapine Fumarate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 04cd529c-198b-5b85-e063-6294a90a4684, effective 20251121; matched on
openfda.generic_name.exact:"QUETIAPINE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,250 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
QUETIAPINE, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.